SchizophreniaPhase 1NCT02174523
Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects
A Phase 1 study testing 40mg lurasidone in people with Schizophrenia, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
To evaluate the pharmacokinetic (PK) characteristics after multiple oral administration of 40 mg lurasidone in healthy Chinese subjects. To evaluate the safety and tolerance after multiple oral administration of 40 mg lurasidone in healthy Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- 40mg lurasidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Apr 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- After detailed explanations of study objectives, methods and procedures, anticipated efficacy, pharmacologic actions, risks and other relevant contents, subjects are aware of all relevant information related to this study and have signed the informed consent form voluntarily.
- Male subjects are 18≤ age <40 years of age when signing the informed consent.
- Subjects with body weight of 50.0≤ and ≤80.0 kg and BMI (body mass index) of 19.0≤ and <24.0 at screening examination.
- Subjects are able to comply with all requirements during this study period, receive various physical and laboratory examinations per study protocol, and report subjective symptoms.
Who cannot join
- Based on the examination results during screening period, various physical and laboratory examinations performed 1 day before medication (Day -1) and before administration of study drug on the medication day, there are certain medical concerns on subject's health status in principal investigator's or study supervising physician's opinions (certain treatment or medical observation are deemed necessary).
- Subjects with past diabetic history.
- Subjects has an HbA1c level of >6.2% at screening.
- Subjects with history of gastrointestinal operations (excluding appendectomy).
- Because of subjects' past medical history of cardiovascular diseases, liver diseases, renal diseases, endocrine disorders, digestive diseases, hematologic diseases, respiratory diseases, mental illness, neurological disorders (especially epilepsy and other convulsive disorders) and other diseases, subjects are unsuitable to participate in this study in the principal investigator's or study supervising physician's opinions.
- Subjects with past history of allergy to drugs.
Show all 20Show fewer
- Subjects have consumed grapefruit or food containing grapefruit ingredients between 7 days before medication (Day_-7) and before administration of study drug on the medication day (Day 1). Subjects have consumed food containing hypericum perforatum L. ingredients between 14 days before medication (Day_-14) and administration of study drug on the medication day (Day 1).
- Subjects have taken any drugs (including over-the-counter drugs) between 7 days before medication (Day_-7) and before administration of study drug on medication day.
- Regular drinker (criteria are mean daily consumption ≥2 bottles of 640 mL beers or Chinese liquor≥150 mL).
- Subjects are used to drink large amount (criteria are daily consumption>1.8 L) of caffeine-containing beverages (e.g. coffee, black tea, green tea, coca cola or nutritional oral solution, etc).
- Subjects have history of drug abuse or positive urine drug tests.
- Subjects with positive immunologic test results.
- Average amount of daily smoking>20 cigarettes.
- Subjects have taken other study drugs within 3 months (Day_-90~Day 1) before medication.
- Subjects received lurasidone orally before.
- Subjects have history of blood donations of 400 mL within 3 months (Day_-90~Day 1) before medication; 200 mL within 1 month (Day_-30~Day 1) before medication; or donation of blood components within 2 weeks (Day_-14~Day 1) before medication.
- Subjects have consumed alcohol-containing food between 3 days before medication 3 (Day_-3) and before administration of study drug on medication day.
- Subjects can not tolerate venipuncture or have poor peripheral venous access.
- Subjects are unwilling to abstain from vigorous exercise from Day_-1 until discharge.
- Other subjects who are unsuitable to participate in this study in principal investigator's or study supervising physician's opinions.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the pharmacokinetic (PK) characteristics after multiple oral administration of 40 mg lurasidone in healthy Chinese subjects.
To evaluate the safety and tolerance after multiple oral administration of 40 mg lurasidone in healthy Chinese subjects.
Read the detailed description
Single oral administration of 40 mg study drug lurasidone or placebo after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg study drug lurasidone or placebo, once daily between Day 4 and Day 8.
- Conditions
- Schizophrenia
- Being tested
- 40mg lurasidone, placebo
- Keywords
- pharmacokinetic, lurasidone, multiple dose
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40mg lurasidoneDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 40mg lurasidone | Experimental | Single oral administration of 40 mg study drug lurasidone after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg study drug lurasidone, once daily between Day 4 and Day 8. Receives: Drug: 40mg lurasidone |
| placebo | Placebo comparator | Single oral administration of 40 mg study drug placebo after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg placebo, once daily between Day 4 and Day 8. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lurasidone Cmax
Maximum (peak) observed drug serum concentration.
Measured: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone AUC 0-24
Measured: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone AUC 0-τ
Measured: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone AUC0-∞
Measured: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone Tmax
Measured: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone λz
Measured: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone t1/2
Measured: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone MRT
Measured: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone CL/F
Measured: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
CLss/F
Measured: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Lurasidone Vz/F
Measured: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone Vzss/F
Measured: Day 8
Accumulation Ratios Lurasidone,Ratio of Cmax,Ratio of AUC0-∞,Ratio of AUC0-τ,
Measured: Day 8/Day 1
Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 4 and Day 5
Measured: Pre-dose (-0.5h) of Day4 and Day5
Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 6 and Day 7
Measured: Pre-dose (-0.5h) of Day6 and Day7
Lurasidone Cmax
Maximum (peak) observed drug serum concentration.
Measured: Day8
Lurasidone AUC 0-24
Measured: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Lurasidone AUC 0-τ
Measured: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Lurasidone AUC0-∞
Measured: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Lurasidone Tmax
Measured: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Lurasidone λz
Measured: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Lurasidone t1/2
Measured: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Lurasidone MRT
Measured: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xuhui Central Hospital, Shanghai
- Responsible party
- Sponsor
- Investigators
- ChaoYing Hu, MD, Principal investigator, Xuhui Center Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174523
- Sponsor's protocol ID
- D1070003
- Status last verified
- Jun 2014
- First submitted
- 11 Feb 2014
- Last updated
- 8 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hu C, Wang Y, Song R, Yu C, Luo X, Jia J. Single- and Multiple-Dose Pharmacokinetics, Safety and Tolerability of Lurasidone in Healthy Chinese Subjects. Clin Drug Investig. 2017 Sep;37(9):861-871. doi: 10.1007/s40261-017-0546-8.
PubMed 28695535
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT02174523
- Acronym / sponsor ID
- D1070003
- Conditions
- Schizophrenia
- Keywords
- pharmacokinetic, lurasidone, multiple dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Xuhui Central Hospital, Shanghai
- Study start
- Apr 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Posted 8 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the pharmacokinetic (PK) characteristics after multiple oral administration of 40 mg lurasidone in healthy Chinese subjects.
To evaluate the safety and tolerance after multiple oral administration of 40 mg lurasidone in healthy Chinese subjects.
Detailed description
Single oral administration of 40 mg study drug lurasidone or placebo after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg study drug lurasidone or placebo, once daily between Day 4 and Day 8.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40mg lurasidone | Experimental | Drug: 40mg lurasidoneSingle oral administration of 40 mg study drug lurasidone after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg study drug lurasidone, once daily between Day 4 and Day 8. |
| placebo | Placebo comparator | Drug: placeboSingle oral administration of 40 mg study drug placebo after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg placebo, once daily between Day 4 and Day 8. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- After detailed explanations of study objectives, methods and procedures, anticipated efficacy, pharmacologic actions, risks and other relevant contents, subjects are aware of all relevant information related to this study and have signed the informed consent form voluntarily.
- Male subjects are 18≤ age <40 years of age when signing the informed consent.
- Subjects with body weight of 50.0≤ and ≤80.0 kg and BMI (body mass index) of 19.0≤ and <24.0 at screening examination.
- Subjects are able to comply with all requirements during this study period, receive various physical and laboratory examinations per study protocol, and report subjective symptoms.
Key exclusion criteria (20 listed)
- Based on the examination results during screening period, various physical and laboratory examinations performed 1 day before medication (Day -1) and before administration of study drug on the medication day, there are certain medical concerns on subject's health status in principal investigator's or study supervising physician's opinions (certain treatment or medical observation are deemed necessary).
- Subjects with past diabetic history.
- Subjects has an HbA1c level of >6.2% at screening.
- Subjects with history of gastrointestinal operations (excluding appendectomy).
- Because of subjects' past medical history of cardiovascular diseases, liver diseases, renal diseases, endocrine disorders, digestive diseases, hematologic diseases, respiratory diseases, mental illness, neurological disorders (especially epilepsy and other convulsive disorders) and other diseases, subjects are unsuitable to participate in this study in the principal investigator's or study supervising physician's opinions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40mg lurasidone | Drug | 40mg lurasidone |
| placebo | Drug | placebo |
Primary outcome
Lurasidone Cmax
Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Maximum (peak) observed drug serum concentration.
Lurasidone AUC 0-24
Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone AUC 0-τ
Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone AUC0-∞
Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone Tmax
Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone λz
Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone t1/2
Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone MRT
Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone CL/F
Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
CLss/F
Time frame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Lurasidone Vz/F
Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone Vzss/F
Time frame: Day 8
Accumulation Ratios Lurasidone,Ratio of Cmax,Ratio of AUC0-∞,Ratio of AUC0-τ,
Time frame: Day 8/Day 1
Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 4 and Day 5
Time frame: Pre-dose (-0.5h) of Day4 and Day5
Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 6 and Day 7
Time frame: Pre-dose (-0.5h) of Day6 and Day7
Lurasidone Cmax
Time frame: Day8
Maximum (peak) observed drug serum concentration.
Lurasidone AUC 0-24
Time frame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Lurasidone AUC 0-τ
Time frame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Lurasidone AUC0-∞
Time frame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Lurasidone Tmax
Time frame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Lurasidone λz
Time frame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Lurasidone t1/2
Time frame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Lurasidone MRT
Time frame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28695535Hu C, Wang Y, Song R, Yu C, Luo X, Jia J. Single- and Multiple-Dose Pharmacokinetics, Safety and Tolerability of Lurasidone in Healthy Chinese Subjects. Clin Drug Investig. 2017 Sep;37(9):861-871. doi: 10.1007/s40261-017-0546-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ChaoYing Hu, MD principal investigator
Xuhui Center Hospital, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 40mg lurasidone in people with Schizophrenia, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lurasidone Cmax (time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02174523, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.